Co-Codamol 8 Mg/500 Mg Tablets
CO-CODAMOL 8 mg/500 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Co-Codamol
carefully to get the best results from it.
• This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by other painkillers such as paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pains, aches and pains.
• You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take this medicine for headaches for more than three days it can make them worse.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Co-Codamol is and what it is used for
2. Before you take Co-Codamol
3. How to take Co-Codamol
4. Possible side effects
5. How to store Co-Codamol
6. Further information
1. WHAT CO-CODAMOL IS AND WHAT IT IS USED FOR
• Your tablets are called Co-Codamol Tablets. They are a mixture of two drugs, codeine phosphate and paracetamol. They are part of a group of drugs known as analgesics (pain killers).
• This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by other painkillers such as paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period pains, aches and pains.
2. BEFORE YOU TAKE CO-CODAMOL
DO NOT take Co-Codamol if you:
• are allergic (hypersensitive) to paracetamol, codeine or any other opioid analgesics, or any of the other ingredients of this medicine listed in section 6, Further information
• are taking any other products containing paracetamol, such as over-the-counter cold remedies
• have recently suffered a head injury or have suffered a serious illness or accident which resulted in increased pressure in the brain
• suffer from alcoholism
• suffer from any disorder which may cause fits
• have breathing problems that are caused by bronchitis or asthma
• are having an asthma attack.
Take special care with Co-Codamol
• Do not take for longer than 3 days without consulting your doctor.
• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take a painkiller for headaches for more than three days it can make them worse.
Tell your doctor before you start to take this medicine if you:
• have any problems with your kidneys or liver
• suffer from an underactive thyroid gland, underactive adrenal glands or an enlarged prostate gland
• have low blood pressure
• have bowel problems
• have myasthenia gravis (muscle weakness)
• are suffering from shock
• suffer from allergies, for example to food, cosmetics, dust or drugs.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• other pain killers which contain codeine
• monoamine oxidase inhibitors (e.g. phenelzine, moclobemide, for treatment of depression), or if you have stopped taking these within the last two weeks
• other medicines which depress the nervous system such as antidepressants (e.g. fluoxetine, amitriptyline), phenothiazines (e.g. chlorpromazine), hypnotics (e.g. temazepam) or sedatives (sleeping tablets)
• anticoagulants e.g. warfarin (to stop your blood clotting)
• medicines for diarrhoea e.g. loperamide or kaolin
• medicines for muscle spasm e.g. dicyclomine or propantheline
• cholestyramine (to lower cholesterol)
• metoclopramide, cisapride or domperidone (to stop you feeling or being sick)
• quinidine or mexiletine (for irregular heart rhythm)
• cimetidine (to reduce stomach acid).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor you are taking Co-Codamol if you are due to have an operation or any treatment
which requires an anaesthetic.
Taking Co-Codamol with food and drink
• Do not drink alcohol while you are taking Co-Codamol.
Pregnancy and breast-feeding
• If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.
• Usually it is safe to take Co-Codamol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
Driving and using machines
• Co-Codamol may cause dizziness or drowsiness. If you are affected, do not drive or operate machinery.
3. HOW TO TAKE CO-CODAMOL
If your doctor has prescribed this medicine, always take Co-Codamol exactly as your doctor has
told you. Otherwise follow the instructions below:
• Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
• This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
• The tablets should be swallowed with a drink of water.
• You should leave at least four hours between doses and you should not take more than four doses in 24 hours.
• Adults and Children over 12 years old
1-2 tablets taken with a drink of water. The dose may be repeated every 4 - 6 hours, with a maximum of 8 tablets in 24 hours.
• Elderly
If you have impaired liver function, it may be advisable for you to take a lower dose than the one normally recommended for adults. Please consult your doctor or pharmacist for advice.
Children under 12 years old
Co-Codamol is not recommended for use in Children under 12 years old.
If you are not sure how to take this medicine talk to your doctor or pharmacist.
If you take more Co-Codamol than you should
If you (or someone else) take too many tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately, even if you feel well, because of the risk of delayed serious liver damage.
An overdose is likely to cause feeling or being sick, loss of appetite, abdominal pain, irregular heartbeat or pin-point pupils.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor if you experience any of the following effects:
• fever or chills, sore throat, ulcers in you mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising
• you seem to be getting more infections than usual
• severe pain in the abdomen or back, usually accompanied by sickness, diarrhoea or fever.
Other side effects that have been reported are:
• feeling sick or being sick
• constipation
• difficulty urinating
• breathing difficulties
• dizziness or a feeling of dizziness or spinning, a fall in blood pressure which causes lightheadedness or fainting
• drowsiness
• confusion
• low blood pressure
• dry mouth
• sweating
• headache
• facial flushing
• slower or faster heartbeat, palpitations
• low body temperature
• hallucinations
• anxiety
• mood changes
• pupils in the eyes may become smaller.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
5. HOW TO STORE CO-CODAMOL
Keep out of the reach and sight of children.
Store in a cool dry place
Do not use Co-Codamol after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Co-Codamol Tablets contain:
• The active ingredients are codeine phosphate 8 mg and paracetamol 500 mg.
• The other ingredients are maize starch, pregelatinised maize starch, povidone, hydroxybenzoate esters, sodium starch glycolate and magnesium stearate.
What Co-Codamol Tablets look like and contents of the pack:
• Co-Codamol Tablets are white, coded “CO-COD 8-500” with a breakline on one side and a twin triangle logo on the reverse side.
• Co-Codamol Tablets are available in packs of 20, 24, 28, 30, and 32 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Ltd, Eastbourne, BN22 9AG
This leaflet was last revised: November 2010 PL 00289/1427